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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Creatinine
510(k) Number K110137
Device Name ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
Applicant
HORIBA ABX SAS
Parc Euromedecine
Rue Du Caducee - Bp7290
Montpellier,  FR 34184
Applicant Contact CAROLINE FERRER
Correspondent
HORIBA ABX SAS
Parc Euromedecine
Rue Du Caducee - Bp7290
Montpellier,  FR 34184
Correspondent Contact CAROLINE FERRER
Regulation Number862.1225
Classification Product Code
JFY  
Subsequent Product Codes
JIX   JJY  
Date Received01/18/2011
Decision Date 08/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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